Catalog Number

-

Brand Name

Chair Sleeves

Version/Model Number

BCCS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NRU

Product Code Name

CHAIR, DENTAL, WITHOUT OPERATIVE UNIT

Public Device Record Key

d95f81d2-b05a-497d-ad03-af0f0d2d0e44

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 19, 2022

Package DI Number

50732224003288

Quantity per Package

4

Contains DI Package

10732224003280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-